Our scientific team presented groundbreaking research on complex generics at the Dubai Pharmaceutical Conference, attended by regulatory authorities and pharmaceutical companies from across the MENA region.
The presentation, delivered by Dr. Sarah Mitchell, focused on bioequivalence methodology for complex drug formulations — an area of growing regulatory interest as generic manufacturers seek approval for more sophisticated drug products.
Research highlights
The study presented demonstrated a novel approach to establishing bioequivalence for modified-release formulations, drawing on data from over 40 studies conducted at PRU's Phase I unit. The methodology has since been referenced in two regulatory submissions to the European Medicines Agency.
Regional collaboration
The conference provided an opportunity to strengthen relationships with regulatory authorities across Jordan, Saudi Arabia, Egypt, and the UAE — reinforcing PRU's position as the region's leading CRO for complex generic development.
